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Last Updated: July 2, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209862


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NDA 209862 describes EVZIO (AUTOINJECTOR), which is a drug marketed by Kaleo Inc and is included in one NDA. It is available from two suppliers. There are thirty patents protecting this drug. Additional details are available on the EVZIO (AUTOINJECTOR) profile page.

The generic ingredient in EVZIO (AUTOINJECTOR) is naloxone hydrochloride. There are twelve drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
Summary for 209862
Tradename:EVZIO (AUTOINJECTOR)
Applicant:Kaleo Inc
Ingredient:naloxone hydrochloride
Patents:30
Formulation / Manufacturing:see details
Pharmacology for NDA: 209862
Mechanism of ActionOpioid Antagonists
Medical Subject Heading (MeSH) Categories for 209862
Suppliers and Packaging for NDA: 209862
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EVZIO (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862 NDA HF Acquisition Co LLC, DBA HealthFirst 51662-1495 51662-1495-1 2 DOSE PACK in 1 CARTON (51662-1495-1) > .4 mL in 1 DOSE PACK
EVZIO (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862 NDA kaleo, Inc. 60842-051 60842-051-01 2 DOSE PACK in 1 CARTON (60842-051-01) > .4 mL in 1 DOSE PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, SUBCUTANEOUSStrength2MG/0.4ML (2MG/0.4ML)
Approval Date:Oct 19, 2016TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 24, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF A DELIVERY DEVICE TO DELIVER A DOSE OF NALOXONE
Patent:  Start TrialPatent Expiration:Mar 20, 2035Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF A DELIVERY DEVICE TO DELIVER A BIOEQUIVALENT DOSE OF A NALOXONE COMPOSITION VIA A NEEDLE
Patent:  Start TrialPatent Expiration:Nov 23, 2024Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Baxter
Dow
Express Scripts
Boehringer Ingelheim
McKinsey
Harvard Business School

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